At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
Nicotine (2 mg) +1 moredrug
Likely dose
Nicotine (2 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges
In Brief
A Phase 1 clinical trial evaluating Nicotine (2 mg) and Nicotine (4 mg) for Smoking Cessation. Completed, enrolled 50 participants across 1 site.
Detailed Summary
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
Primary CompletionAug 2011
First PostedFeb 2012
TodayJul 2026
First PostedFeb 22, 2012
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.4 years ago
Interventions
Nicotine (2 mg)drug
2 mg nicotine lozenge in two formulations
Nicotine (4 mg)drug
4 mg nicotine lozenge in two formulations